Cleared Traditional

K801552 - MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR

K801552 is an FDA 510(k) clearance for MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR, manufactured by Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801552 · Edwards Laboratories · Cardiovascular device
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Jul 1980
Decision
20d
Days
Class 2
Risk

K801552 is an FDA 510(k) clearance for the MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edwards Laboratories devices

FDA 510(k) Submission Details - K801552

510(k) Number K801552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date July 28, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRB Device Classification - Class 2, Special Controls

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRB Probe, Thermodilution

All 27
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K801552.
THERMODILUTION KIT
K811480 · American Pharmaseal Div. Ahsc · Jun 1981
MODEL SP5107 THERMODILUTION CATHETER
K810730 · Gould, Inc. · Mar 1981
BENTLEY THEROMODILUTION CATHETER #BTD-7F
K802133 · Bentley Laboratories, Inc. · Sep 1980
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873 · C.R. Bard, Inc. · Nov 1979
CATHETER, THERMAL DILUTION, ANIMAL & PED
K760064 · Instrumentation Laboratory CO · Jul 1976
CATHETER, THERMAL DILUTION, PEDIATRIC
K760065 · Instrumentation Laboratory CO · Jul 1976